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LONDON – The European Medicines Regulatory Agency has recommended the approval of the first dengue vaccine despite concerns over its widespread use and legal action in the Philippines alleging that it was linked to three deaths.
The European Medicines Agency announced Friday that it has adopted a "positive opinion" on the Dengvaxia of the French pharmaceutical group Sanofi. This vaccine is the first in the world to fight dengue fever, which affects about 96 million people a year.
The virus spread by mosquitoes occurs in tropical and subtropical climates of Latin America and South America, Asia, Africa and elsewhere. The result is a flu-like illness that can cause joint pain, nausea, vomiting and rash. In severe cases, dengue fever can lead to breathing problems, haemorrhage and organ failure.
There is no specific treatment for dengue fever and there are no other licensed vaccines on the market.
Earlier this year, the World Health Organization declared that the vaccine should be treated "much safer" and that it should be administered primarily to people who already have dengue fever. The vaccine is registered for use in approximately 20 countries.
The UN health agency said there were "significant obstacles" to the use of the vaccine and a quick test should be developed to determine if people had already been infected with dengue fever.
Sanofi had previously warned that people who had never had dengue fever risked getting a more serious illness after receiving the vaccine. The company said it was expecting to suffer a loss of 100 million euros ($ 118 million) on the basis of this news.
The Philippines was the first country to implement a national dengue vaccination program – which it discontinued after Sanofi announced last year. The government also asked Sanofi to repay more than 3 billion pesos ($ 59 million). In February, the Philippines said the vaccine was potentially linked to the deaths of three people: all died of dengue while they had been vaccinated against dengue fever.
The country imposed a symbolic fine of $ 2,000 on Sanofi and suspended the approval of the vaccine, accusing the drug maker of violating the rules on registration and marketing of the vaccine.
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